Betting on Substance: Full-Cycle Technology Platforms as a Matter of Pharmaceutical Sovereignty

To achieve national pharmaceutical security, countries need to reduce their critical reliance on imported active pharmaceutical ingredients (APIs). Many of the APIs needed to manufacture medicinal products in Russia currently originate abroad, which jeopardizes the stability of supplies and limits the industry’s sovereignty. Today, the pharmaceutical sector faces the challenge of synchronizing scientific, manufacturing, and regulatory solutions in order to achieve the objectives contained in the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation until 2030. As part of this process, it is crucial to both reduce dependence on imported APIs for the production of generic medicines as well as create an innovation-friendly environment in which new medicinal products cannot be developed without the required expertise and experience in creating and manufacturing pharmaceutical APIs. Which state regulatory measures are most effective in supporting API manufacturers? How quickly will the range of medicinal products manufactured using domestic APIs be expanded and based on what criteria? What level of localization is required in terms of technological processing stages (sequential steps of chemical synthesis) for a substance to be granted domestic status?